JP2004537389A - Interspinous prosthesis - Google Patents

Interspinous prosthesis Download PDF

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JP2004537389A
JP2004537389A JP2003520408A JP2003520408A JP2004537389A JP 2004537389 A JP2004537389 A JP 2004537389A JP 2003520408 A JP2003520408 A JP 2003520408A JP 2003520408 A JP2003520408 A JP 2003520408A JP 2004537389 A JP2004537389 A JP 2004537389A
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prosthesis
mating member
interspinous
extension
central axis
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JP4947879B2 (en
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マチュー、クラウド
レックマン、ベート
パヴロフ、ポウル
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AO Technology AG
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Synthes AG Chur
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7068—Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Neurology (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

棘突起間プロテーゼ（１）が棘突起間空間に導入可能な中間部分（２）を有し、この中間部分が中心軸線（４）と内端（７）と外端（８）とこの外端（８）から出発して中心軸線（４）に対して半径方向および直径方向に延びる延長部（３）とを有し、この延長部が２つの隣接する錐体の棘突起間空間に導入可能であり、プロテーゼ（１）に対して実質的に対称な相手部材（６）を受容するために中間部分（２）が、延長部（３）から離れた方のその内端（７）に軸線方向凹部（５）を有する。The interspinous process prosthesis (1) has an intermediate portion (2) that can be introduced into the interspinous space, the intermediate portion being a central axis (4), an inner end (7), an outer end (8) and an outer end. An extension (3) extending radially and diametrically with respect to the central axis (4) starting from (8), which can be introduced into the interspinous space of two adjacent cones An intermediate portion (2) for receiving a mating member (6) substantially symmetrical with respect to the prosthesis (1) has an axial end at its inner end (7) remote from the extension (3). It has a direction recess (5).

Description

【技術分野】
【０００１】
本発明は、請求項１の前文に係る棘突起間プロテーゼ、その相手部材、およびこれから組合せられた多部分構成の棘突起間プロテーゼに関する。
【背景技術】
【０００２】
このようなプロテーゼは、椎体の間の距離を本来なら狭めるであろうような椎間板欠損時に２つの隣接する椎体用のスペーサとして役立つ。距離を再び拡大することによって椎間関節も負担軽減される。
【０００３】
ＷＯ９９／４２０５１により前文に係る棘突起間プロテーゼが公知であり、このプロテーゼは棘突起間空間に導入すべき中央部材を含み、‐移植実行後に‐２つの隣接する椎体の棘突起（processus spinosus）間空間内で中央部材を固定するために、この中央部材から頭方および尾方で各１対の耳片が中央部材の左右に延びている。この公知プロテーゼでは欠点としてその一体性が移植を困難とし、こうして棘上靭帯の除去が必要となる。この靭帯の除去は、プロテーゼが背側では確たる支えを持たないという他の欠点をもたらす。この理由からＷＯ９９／４２０５１では、プロテーゼの棘突起間中央部材に穿孔してそのなかに帯を挿通し、この帯でプロテーゼを隣接する椎体の棘突起に結び付けることができるようにすることが提案される。この仕方はきわめて時間がかかり複雑である。
【０００４】
先行技術の上記論議は本発明を取り巻く環境を説明するために行われるにすぎず、引用された先行技術がこの出願またはその優先権の時点に実際に刊行されまたは一般に周知でもあったことを意味するのではない。
【０００５】
この点で本発明は救済策を提供せんとするものである。本発明の課題は、手術を全体として一層優しく行うことができかつ背側でのインプラントの保全が付加的手段なしに保証されているように、棘上靭帯を維持して移植することのできる棘突起間プロテーゼを提供することである。
【０００６】
本発明はこの課題を多部分構成の棘突起間プロテーゼで解決し、その際個々の部分は異なる機械的性質を有することができる。
【０００７】
本発明に係る棘突起間プロテーゼは実質的に棘突起間空間に導入可能な中間部分を含み、この中間部分は中心軸線と外端から出発して中心軸線に対して半径方向および直径方向に延びる２つの延長部とを有し、延長部は隣接する２つの椎体の棘突起間空間に導入可能である。さらに、中間部分には延長部から離れた方のその内端に軸線方向凹部が設けられており、この凹部はプロテーゼに対して実質的に対称な相手部材を受容するのに役立つ。
【０００８】
好ましい実施形態において中間部分が連結手段を有し、この連結手段で相手部材がプロテーゼに固定可能である。プロテーゼにおける延長部の位置と相手部材における延長部の位置が相手部材の固定時に互いに相対的に決定されているように連結手段は仕上げられている。好ましくは連結手段は止めを有する差込継手からなり、こうして相手部材をプロテーゼに固着するとプロテーゼおよび相手部材の延長部がその所要位置を占める。差込継手の代りに両方の部分はねじ結合部または円錐体結合部によって互いに固定することができ、その場合プロテーゼと相手部材は好ましくは回転防止部を備えており、こうして相手部材は特定位置でのみプロテーゼの軸線方向凹部に導入可能である。他の構成の連結手段は少なくとも１つの弾性変形可能なカムであり、プロテーゼと相手部材との組立後にこのカムは相手部材に係止可能または係合可能である。
【０００９】
本発明に係るプロテーゼの他の好ましい実施形態において連結手段は少なくとも１つの弾性変形可能なカムを含み、プロテーゼと相手部材との組立時にこのカムが弾性変形可能であり、またプロテーゼと相手部材との組立後は相補的凹部内に係合可能である。
【００１０】
好ましい１構成における、中心軸線に直角な横断面平面において：
ａ）中間部分は最も狭い個所で内端領域の面積が５０〜３００ｍｍ２、好ましくは７０〜２５０ｍｍ２であり、
ｂ）延長部の面積が７０〜５００ｍｍ２、好ましくは１００〜４５０ｍｍ２である。
【００１１】
さらに、プロテーゼは好ましくは弾性材料から作製されており、こうして中間部分は半径方向で弾性変形可能である。十分な半径方向弾性変形能はプロテーゼをプラスチックから製造することによって、または半径方向弾性変形可能な舌片を有する中間部分を形成することによって、達成可能である。
【００１２】
プロテーゼはエラストマー、シリコン、またはポリカーボネート系の高分子から作製することができる。しかし、棘突起間空間内に置かれる中間部分の領域でプロテーゼの弾性が好適な機械的装置によって実現されるなら、金属材料からプロテーゼを仕上げることも可能である。
【００１３】
本発明に係るプロテーゼの他の実施形態においてプロテーゼは中空に構成されており、その際中空壁はコラプシブルに構成しおよび／または空洞の充填によって膨張可能としておくことができる。コラプシブルな中空壁は、弾性材料が可能とするよりも大きなプロテーゼ変形をこれによって可能とできる利点を有する。
【００１４】
内端領域で中間部分はその外面を平滑または粗面に構成しておくことができる。外面のこの構成によって骨の成長に影響を及ぼすことができ、粗い外面はプロテーゼに沿って骨の成長を促進する一方、平滑な外面はこの成長を困難にしまたは妨げることさえある。骨に接触したインプラントの表面はヒドロキシアパタイト（ＨＡ）を埋め込むことによって保護することもできる。
【００１５】
好ましい実施形態において本発明に係る相手部材は内端と外端とこの外端から出発したやはり半径方向および直径方向に延びる２つの延長部とを含み、延長部は隣接する２つの椎骨の棘突起の間のプロテーゼに対向する空間内に挿入可能である。さらに、相手部材にピンが内端に向けて取付けられており、このピンがプロテーゼの凹部に導入可能である。こうして移植時にプロテーゼと相手部材との厳密な整列を達成することができる。
【００１６】
プロテーゼと同様に相手部材は類似もしくは相補的連結手段を装備しておくことができる。やはりこれらの連結手段は差込継手、弾性変形可能なカム、ねじ結合部または円錐体結合部を含むことができる。同様に相手部材に類似もしくは相補的回転防止部を取付けておくことができる。
【００１７】
相手部材を有する本発明に係る棘突起間プロテーゼの好ましい実施形態は、組立状態のときプロテーゼが中心軸線に直角な対称平面を有し、棘突起間プロテーゼの延長部が相手部材の延長部に対して中心軸線と平行に見て少なくとも２ｍｍ、好ましくは少なくとも３ｍｍの距離を有する。棘突起間プロテーゼの延長部と相手部材の延長部との最大距離は１５ｍｍ、好ましくは１２ｍｍである。
以下、複数の実施例の一部略示した図面を基に本発明と本発明の諸構成をなお詳しく説明する。
【００１８】
図１に棘突起間プロテーゼ１が相手部材６と組立状態で示してある。プロテーゼ１の中間部分２はプロテーゼ１の内端７が相手部材６に隣接している。プロテーゼ１の外端８に両方の延長部３が中心軸線４に垂直に、互いに直径上で向き合わせて配置されている。延長部３はここに示す実施形態では楕円体の半片として実施されている。相手部材６のやはり半径方向および互いに直径方向で向き合う延長部３は中心軸線４に直角な平面に対して対称に配置されている。中心軸線４と平行に見たプロテーゼ１の横断面において対称に配置される半径方向カム１７がプロテーゼ１と相手部材６との間の回転防止部として役立ち、このカムは中間部分２でプロテーゼ１の内端７から突出し、相手部材６の相補的溝１８内に係合する。中心軸線４と同軸で中間部分２が凹部５を含み、この凹部は内端７の方からプロテーゼ１内に深さＴまで達している。相手部材６が栓１６を有し、この栓は凹部５に対して相補的に構成されており、従ってプロテーゼ１と相手部材６を組立てると凹部５内に導入可能である。
【００１９】
さらにプロテーゼ１は、プロテーゼ１の外端８に当接可能なボルト頭部２６を有する固定ボルト１９を含む。固定ボルト１９は中心軸線４と同軸でプロテーゼ１に挿通可能であり、相手部材６の栓１６内で差込継手２７によって係止可能であり、こうしてプロテーゼ１は相手部材６と脱離可能に鎖錠可能である。固定ボルト１９と相手部材６は中心軸線４と同軸な穴２０が連続的に穿孔され、こうしてプロテーゼ１と相手部材６は半径方向でコラプシブルである。
【００２０】
図２は相手部材６を有するプロテーゼ１の他の実施形態を組立状態で示す。凹部５はプロテーゼ１を同軸で内端７から外端８まで貫通している。相手部材６の栓１６はプロテーゼ１と相手部材６を組立てると連続した凹部内に、プロテーゼ１の内端７が相手部材６の延長部３に当接するまで押し込まれる。さらに、相手部材６は外端１５と内端１４との間を穴２０と連続的に穿孔されている。連結手段１１はねじ結合部として構成されており、ねじ２１はプロテーゼ１の凹部５と相手部材６の穴２０とに通してプロテーゼ１の外端８から相手部材６の外端１５に至るまで挿通され、ナット２２で鎖錠可能である。さらに、プロテーゼ１が空洞１２付きで構成されており、こうして空洞壁１３は選択的にコラプシブル、または空洞１２に充填材を充填することによって膨張可能である。
【００２１】
図３に示す実施形態が上記実施形態と相違する点として、相手部材６の栓１６がプロテーゼ１の凹部５に完全に挿通され、こうして相手部材６の内端１４がプロテーゼ１の外端８と一直線に並ぶ。さらに、相手部材６は内端１４から外端１５に至るまで連続した複数の穴２０を有し、それらの穴軸線は中心軸線４と平行に延びている。これらの穴２０にセルクラージュ針金２３を通すことができ、セルクラージュ針金は棘突起間プロテーゼ１および相手部材６を固定するのに役立つ。
【００２２】
図４に示す実施形態は、連結手段１１が係止ボルト２８を含み、この係止ボルトが中心軸線４と同軸でプロテーゼ１および相手部材６を貫通した穴２０に挿通可能であることによって、図１に示す実施形態と相違しているにすぎない。係止ボルト２８はその頭部２９が相手部材６の外端１５に当接可能であり、またその先端には半径方向変形可能なカム３１を有する。このカムはプロテーゼ１と相手部材６とを組立てると穴２０の直径よりも大きな直径の旋削部３０内に係合することができ、こうしてプロテーゼ１と相手部材６はしっかり保持される。係止ボルト２８を穴２０に導入するためにカム３１は軸線方向に配置される溝孔３２によって中心軸線４に垂直に圧縮することができ、こうして係止ボルト２８が穴２０に挿通可能である一方、組立状態のときカム３１は弾力的にばね力で戻り、プロテーゼ１の旋削部３０内に係合する。係止ボルト２８は中心軸線４と同軸で連続的に穿孔されており、こうしてピン２５が挿通可能であり、これによりカム３１の半径方向ばね伸縮が妨げられる。
【００２３】
図５には相手部材６を有する本発明に係るプロテーゼ１の他の実施形態が示してある。プロテーゼ１の外端８と相手部材６の外端１５とに延長部３が中心軸線４に垂直にかつ互いに直径上で向き合わせて取付けられており、この実施形態において延長部３は中心軸線４と平行に半円形横断面を有する。凹部５はプロテーゼ１を内端７から外端８に至るまで中心軸線４と同軸で貫通している。極く大きなねじピッチを有する雌ねじ３６が凹部５内に取付けられている。相手部材６はやはり内端１４に隣接して栓１６を有し、この栓が雌ねじ３６に相補的な雄ねじ３３を有し、こうしてプロテーゼ１と相手部材６はこのねじ結合部によって互いに脱離可能に固着可能である。栓１６と延長部３との間で相手部材６に第１鋸歯状歯３４が取付けられており、この歯はプロテーゼ１を相手部材６と組立てるとプロテーゼ１の内端７の相補的第２歯３５とかみ合うことができ、こうして歯３４；３５の非対称構成によってプロテーゼ１および相手部材６の意図しない脱離に備えた安全が講じられる。
【図面の簡単な説明】
【００２４】
【図１ａ】相手部材を有する本発明に係る棘突起間プロテーゼの好ましい実施形態の断面図である。
【図１ｂ】相手部材を有する本発明に係るプロテーゼの図１ａに示す実施形態の側面図である。
【図２】相手部材を有する本発明に係る棘突起間プロテーゼの他の実施形態の断面図である。
【図３】相手部材を有する本発明に係る棘突起間プロテーゼの他の実施形態のやはり断面図である。
【図４】相手部材を有する本発明に係る棘突起間プロテーゼの他の実施形態の断面図である。
【図５】相手部材を有する本発明に係る棘突起間プロテーゼの他の実施形態の図である。
【符号の説明】
【００２５】
１ プロテーゼ ２ 中間部分 ３ 延長部
４ 中心軸線 ５ 軸線方向凹部 ６ 相手部材
７、１４ 内端 ８、１５ 外端 １１ 連結手段
１２ 空洞 １３ 空洞壁 ２０ 穴
２７ 差込継手 ３１ カム【Technical field】
[0001]
The present invention relates to an interspinous prosthesis according to the preamble of claim 1, its counterpart and a multipart interspinous prosthesis combined therewith.
[Background Art]
[0002]
Such a prosthesis serves as a spacer for two adjacent vertebral bodies during an intervertebral disc defect that would otherwise reduce the distance between the vertebral bodies. By increasing the distance again, the facet joints are also relieved.
[0003]
WO 99/42051 discloses an interspinous prosthesis according to the preamble, which comprises a central member to be introduced into the interspinous space, after the implantation has been carried out,-the processus spinosus of two adjacent vertebral bodies In order to secure the central member in the interspace, a pair of earpieces extend from the central member to the left and right of the central member in the head and tail directions. The disadvantage of this known prosthesis is that its integrity makes implantation difficult, and thus the removal of the supraspinous ligament. This removal of the ligament has the other disadvantage that the prosthesis has no solid support on the back. For this reason, WO 99/42051 proposes to pierce the interspinous central member of the prosthesis and to insert a band into it so that the band can tie the prosthesis to the spinous process of the adjacent vertebral body. Is done. This is very time consuming and complicated.
[0004]
The above discussion of the prior art is intended only to illustrate the environment surrounding the present invention, which means that the cited prior art was actually published or commonly known at the time of this application or its priority. Don't do it.
[0005]
In this regard, the present invention seeks to provide no remedy. SUMMARY OF THE INVENTION It is an object of the present invention to provide a spine capable of maintaining and implanting a supraspinal ligament such that the operation can be performed more gently as a whole and the integrity of the implant on the dorsal side is ensured without additional measures. It is to provide an inter-prosthesis prosthesis.
[0006]
The present invention solves this problem with a multi-part interspinous prosthesis, wherein the individual parts can have different mechanical properties.
[0007]
An interspinous prosthesis according to the present invention includes an intermediate portion substantially introduceable into the interspinous space, the intermediate portion extending radially and diametrically relative to the central axis starting from a central axis and an outer end. And two extensions that can be introduced into the interspinous space of two adjacent vertebral bodies. In addition, the intermediate portion is provided with an axial recess at its inner end remote from the extension, which serves to receive a substantially symmetric counterpart with respect to the prosthesis.
[0008]
In a preferred embodiment, the intermediate part has a connecting means by means of which the counterpart can be fixed to the prosthesis. The coupling means is finished so that the position of the extension in the prosthesis and the position of the extension in the mating member are determined relative to each other when the mating member is fixed. Preferably, the connecting means comprises a bayonet joint having a stop, so that when the counterpart is secured to the prosthesis, the prosthesis and the extension of the counterpart occupy its required position. Instead of a bayonet joint, both parts can be secured to one another by a threaded connection or a conical connection, in which case the prosthesis and the counterpart are preferably provided with anti-rotation parts, so that the counterpart is in a specific position. Only the prosthesis can be introduced into the axial recess. Another configuration of the connecting means is at least one elastically deformable cam, which can be locked or engageable with the mating member after assembling the prosthesis with the mating member.
[0009]
In another preferred embodiment of the prosthesis according to the invention, the coupling means comprises at least one elastically deformable cam, which cam can be elastically deformed when assembling the prosthesis and the mating member, and the connection between the prosthesis and the mating member. After assembly, it can be engaged in the complementary recess.
[0010]
In a preferred configuration, in a cross-sectional plane perpendicular to the central axis:
a) intermediate section area of the inner end region at the narrowest point 50 to 300 mm 2, preferably 70~250mm 2,
b) the area of the extension is 70~500mm 2, preferably 100~450mm 2.
[0011]
Furthermore, the prosthesis is preferably made of an elastic material, so that the intermediate part is elastically deformable in the radial direction. Sufficient radial elastic deformability can be achieved by manufacturing the prosthesis from plastic or by forming an intermediate portion with a radially elastically deformable tongue.
[0012]
The prosthesis can be made from an elastomer, silicone, or polycarbonate-based polymer. However, it is also possible to finish the prosthesis from a metallic material, provided that the elasticity of the prosthesis is achieved by means of a suitable mechanical device in the region of the intermediate part located in the interspinous space.
[0013]
In another embodiment of the prosthesis according to the invention, the prosthesis is designed to be hollow, whereby the hollow wall can be made collapsible and / or inflatable by filling the cavity. Collapsible hollow walls have the advantage that larger prosthesis deformations are thereby possible than are possible with elastic materials.
[0014]
In the inner end region, the intermediate part can have its outer surface configured to be smooth or rough. This configuration of the outer surface can affect bone growth, with a rough outer surface promoting bone growth along the prosthesis, while a smooth outer surface can make this growth difficult or even impede. The surface of the implant in contact with the bone can also be protected by implanting hydroxyapatite (HA).
[0015]
In a preferred embodiment, the counterpart according to the invention comprises an inner end and an outer end and two extensions, also radially and diametrically, extending from this outer end, the extensions being the spinous processes of two adjacent vertebrae In the space opposite the prosthesis. Furthermore, a pin is attached to the mating member toward the inner end, and this pin can be introduced into the recess of the prosthesis. Thus, strict alignment between the prosthesis and the mating member during implantation can be achieved.
[0016]
Like the prosthesis, the counterpart can be equipped with similar or complementary coupling means. Again, these connecting means may include bayonet joints, elastically deformable cams, screw connections or cone connections. Similarly, a similar or complementary anti-rotation part can be attached to the mating member.
[0017]
A preferred embodiment of an interspinous prosthesis according to the present invention having a mating member is that, when assembled, the prosthesis has a plane of symmetry perpendicular to the central axis and the extension of the interspinous prosthesis is relative to the extension of the mating member. At a distance of at least 2 mm, preferably at least 3 mm when viewed parallel to the central axis. The maximum distance between the extension of the interspinous prosthesis and the extension of the mating member is 15 mm, preferably 12 mm.
Hereinafter, the present invention and various configurations of the present invention will be described in more detail with reference to the drawings schematically showing a plurality of embodiments.
[0018]
FIG. 1 shows the interspinous process prosthesis 1 in an assembled state with a mating member 6. The intermediate portion 2 of the prosthesis 1 has the inner end 7 of the prosthesis 1 adjacent to the mating member 6. At the outer end 8 of the prosthesis 1 both extensions 3 are arranged perpendicular to the central axis 4 and diametrically opposite one another. The extension 3 is embodied as an ellipsoid half in the embodiment shown here. The extensions 3 of the mating member 6 which are also radially and diametrically opposite one another are arranged symmetrically with respect to a plane perpendicular to the central axis 4. A radial cam 17 which is arranged symmetrically in a cross section of the prosthesis 1 as viewed parallel to the central axis 4 serves as an anti-rotation between the prosthesis 1 and the mating member 6, which cam at the intermediate part 2 of the prosthesis 1 It projects from the inner end 7 and engages in the complementary groove 18 of the mating member 6. Coaxial with the central axis 4, the intermediate part 2 comprises a recess 5, which extends from the inner end 7 into the prosthesis 1 to a depth T. The mating member 6 has a plug 16 which is constructed complementary to the recess 5 and can therefore be introduced into the recess 5 when the prosthesis 1 and the mating member 6 are assembled.
[0019]
Further, the prosthesis 1 includes a fixing bolt 19 having a bolt head 26 that can abut the outer end 8 of the prosthesis 1. The fixing bolt 19 is coaxial with the central axis 4 and can be inserted into the prosthesis 1 and can be locked in the plug 16 of the mating member 6 by a bayonet joint 27, so that the prosthesis 1 is detachably linked to the mating member 6. Lockable. The fixing bolt 19 and the mating member 6 are continuously drilled with a hole 20 coaxial with the central axis 4, so that the prosthesis 1 and the mating member 6 are radially collapsible.
[0020]
FIG. 2 shows another embodiment of the prosthesis 1 having the mating member 6 in an assembled state. The recess 5 penetrates the prosthesis 1 coaxially from the inner end 7 to the outer end 8. The plug 16 of the mating member 6 is pushed into the continuous concave portion when the prosthesis 1 and the mating member 6 are assembled until the inner end 7 of the prosthesis 1 contacts the extension 3 of the mating member 6. Further, the mating member 6 is continuously formed with the hole 20 between the outer end 15 and the inner end 14. The connecting means 11 is configured as a screw connection, and the screw 21 is inserted through the recess 5 of the prosthesis 1 and the hole 20 of the mating member 6 from the outer end 8 of the prosthesis 1 to the outer end 15 of the mating member 6. Then, the nut 22 can be locked. Furthermore, the prosthesis 1 is configured with a cavity 12, so that the cavity wall 13 can be selectively collapsible or expandable by filling the cavity 12 with a filler.
[0021]
3 differs from the above embodiment in that the plug 16 of the mating member 6 is completely inserted into the recess 5 of the prosthesis 1 and thus the inner end 14 of the mating member 6 is connected to the outer end 8 of the prosthesis 1. Align straight. Further, the mating member 6 has a plurality of holes 20 that are continuous from the inner end 14 to the outer end 15, and their hole axes extend parallel to the central axis 4. These holes 20 allow the passage of cerclage wires 23, which serve to secure the interspinous prosthesis 1 and the mating member 6.
[0022]
The embodiment shown in FIG. 4 is illustrated by the fact that the coupling means 11 comprises a locking bolt 28 which is coaxial with the central axis 4 and can be inserted through a hole 20 which passes through the prosthesis 1 and the mating member 6. It is only different from the embodiment shown in FIG. The locking bolt 28 has a head 29 capable of abutting against the outer end 15 of the mating member 6 and a distal end having a cam 31 which can be deformed in the radial direction. The cam can be engaged in a turning portion 30 having a diameter larger than the diameter of the hole 20 when the prosthesis 1 and the mating member 6 are assembled, so that the prosthesis 1 and the mating member 6 are securely held. The cam 31 can be compressed perpendicularly to the central axis 4 by axially arranged slots 32 for introducing the locking bolts 28 into the holes 20, so that the locking bolts 28 can be inserted through the holes 20. On the other hand, in the assembled state, the cam 31 resiliently returns with a spring force and engages in the turned part 30 of the prosthesis 1. The locking bolt 28 is continuously drilled coaxially with the center axis 4 so that the pin 25 can be inserted, thereby preventing the cam 31 from radially expanding and contracting.
[0023]
FIG. 5 shows another embodiment of the prosthesis 1 according to the present invention having a mating member 6. An extension 3 is attached to the outer end 8 of the prosthesis 1 and the outer end 15 of the mating member 6 perpendicular to the central axis 4 and diametrically opposite one another, in this embodiment the extension 3 is And has a semicircular cross section in parallel. The recess 5 penetrates the prosthesis 1 coaxially with the central axis 4 from the inner end 7 to the outer end 8. A female screw 36 having an extremely large screw pitch is mounted in the recess 5. The mating member 6 also has a plug 16 adjacent to the inner end 14, which plug has an external thread 33 complementary to the female thread 36, so that the prosthesis 1 and the mating member 6 can be detached from each other by this screw connection. Can be fixed to A first serrated tooth 34 is mounted on the mating member 6 between the plug 16 and the extension 3, this tooth being a complementary second tooth on the inner end 7 of the prosthesis 1 when the prosthesis 1 is assembled with the mating member 6. 35, and thus the asymmetric configuration of the teeth 34; 35 provides security against unintended disengagement of the prosthesis 1 and the mating member 6.
[Brief description of the drawings]
[0024]
FIG. 1a is a cross-sectional view of a preferred embodiment of an interspinous process prosthesis according to the present invention having a mating member.
FIG. 1b is a side view of the embodiment shown in FIG. 1a of a prosthesis according to the invention having a mating member.
FIG. 2 is a cross-sectional view of another embodiment of an interspinous prosthesis according to the present invention having a mating member.
FIG. 3 is again a cross-sectional view of another embodiment of an interspinous process prosthesis according to the present invention having a mating member.
FIG. 4 is a cross-sectional view of another embodiment of an interspinous process prosthesis according to the present invention having a mating member.
FIG. 5 is a view of another embodiment of an interspinous process prosthesis according to the present invention having a mating member.
[Explanation of symbols]
[0025]
DESCRIPTION OF SYMBOLS 1 Prosthesis 2 Intermediate part 3 Extension part 4 Central axis line 5 Axial concave part 6 Counterpart member 7, 14 Inner end 8, 15 Outer end 11 Connecting means 12 Cavity 13 Cavity wall 20 Hole 27 Insertion joint 31 Cam

Claims (32)

棘突起間プロテーゼであって、棘突起間空間に導入可能な中間部分（２）を有し、この中間部分が中心軸線（４）と内端（７）と外端（８）とこの外端（８）から出発して中心軸線（４）に対して半径方向および直径方向に延びる２つの延長部（３）とを有し、この延長部が隣接する２つの椎体の棘突起間空間内に導入可能であり、中間部分（２）が、延長部（３）から離反した方のその内端（７）に、プロテーゼ（１）に対して実質的に対称な相手部材（６）を受容するための軸線方向凹部（５）を有するものにおいて、
プロテーゼが弾性材料からなり、この材料が中間部分（２）の最も狭い個所（１０）で未負荷直径に対して相対的に直径の１０〜６０％弾性変形を可能とすることを特徴とするプロテーゼ（１）。An interspinous prosthesis having an intermediate portion (2) that can be introduced into the interspinous space, the intermediate portion having a central axis (4), an inner end (7), an outer end (8), and an outer end. Starting from (8) and having two extensions (3) extending radially and diametrically with respect to the central axis (4), the extensions being in the interspinous space of two adjacent vertebral bodies. The intermediate part (2) receives at its inner end (7) remote from the extension (3) a mating member (6) substantially symmetrical to the prosthesis (1) Having an axial recess (5) for
The prosthesis is made of an elastic material, said material allowing elastic deformation of the intermediate portion (2) at its narrowest point (10) 10 to 60% of its diameter relative to the unloaded diameter. (1). 中間部分（２）が連結手段（１１）を有し、この連結手段で相手部材（６）が中間部分に固定可能であることを特徴とする、請求項１記載のプロテーゼ（１）。2. Prosthesis (1) according to claim 1, characterized in that the intermediate part (2) has a connecting means (11) by means of which the mating member (6) can be fixed to the intermediate part. 中心軸線（４）に直角な横断面平面（９）において中間部分（２）が内端（７）領域の最も狭い個所（１０）に５０〜３００ｍｍ２、好ましくは７０〜２５０ｍｍ２の面積を有することを特徴とする、請求項１または２記載のプロテーゼ（１）。The central axis (4) to 50 to 300 mm 2 in the intermediate portion (2) is an inner end (7) the narrowest point of the region (10) in a perpendicular cross-sectional plane (9), preferably has an area of 70～250Mm 2 A prosthesis (1) according to claim 1 or 2, characterized in that: 中心軸線（４）に直角な横断面平面において延長部（３）が７０〜５００ｍｍ２、好ましくは１００〜４５０ｍｍ２の面積を有することを特徴とする、請求項１〜３のいずれか１項記載のプロテーゼ（１）。Extensions in perpendicular cross-sectional plane the central axis (4) (3) is 70~500mm 2, preferably characterized in that it has an area of 100~450mm 2, any one of claims 1 to 3 Prosthesis (1). 弾性材料が未負荷直径に対して相対的に１５〜５０％の弾性変形を可能とすることを特徴とする、請求項１〜４のいずれか１項記載のプロテーゼ（１）。The prosthesis (1) according to any of the preceding claims, characterized in that the elastic material allows an elastic deformation of 15 to 50% relative to the unloaded diameter. プロテーゼがショア硬さ６５Ａ〜９０Ａのプラスチックからなることを特徴とする、請求項１〜５のいずれか１項記載のプロテーゼ（１）。The prosthesis (1) according to any of the preceding claims, characterized in that the prosthesis consists of a plastic with a Shore hardness of 65A to 90A. プロテーゼが金属材料からなり、中間部分（２）が半径方向弾性変形可能な舌片を含むことを特徴とする、請求項１〜５のいずれか１項記載のプロテーゼ（１）。A prosthesis (1) according to any of the preceding claims, characterized in that the prosthesis is made of a metallic material and the intermediate part (2) comprises a tongue which can be elastically deformed in the radial direction. プロテーゼが中空に構成されており、その空洞壁（１３）が選択的にコラプシブル、または空洞（１２）に充填材を充填することによって膨張可能であることを特徴とする、請求項１〜７のいずれか１項記載のプロテーゼ（１）。8. The prosthesis according to claim 1, wherein the prosthesis is hollow and the cavity wall (13) is selectively collapsible or expandable by filling the cavity (12) with filler. The prosthesis (1) according to any one of the preceding claims. 中間部分（２）がその内端（７）の領域でその外面は平滑に構成されていることを特徴とする、請求項１〜８のいずれか１項記載のプロテーゼ（１）。9. Prosthesis (1) according to any of the preceding claims, characterized in that the intermediate part (2) is in the region of its inner end (7) and its outer surface is smooth. 中間部分（２）がその内端（７）の領域でその外面は粗面化されていることを特徴とする、請求項１〜８のいずれか１項記載のプロテーゼ（１）。9. Prosthesis (1) according to any of the preceding claims, characterized in that the intermediate part (2) has a roughened outer surface in the region of its inner end (7). その表面の少なくとも一部でヒドロキシアパタイト（ＨＡ）がプロテーゼ材料に埋め込まれていることを特徴とする、請求項１〜１０のいずれか１項記載のプロテーゼ（１）。The prosthesis (1) according to any of the preceding claims, characterized in that hydroxyapatite (HA) is embedded in the prosthesis material on at least a part of its surface. 連結手段（１１）が差込継手（２７）を含むことを特徴とする、請求項２〜１１のいずれか１項記載のプロテーゼ（１）。12. Prosthesis (1) according to any of the claims 2 to 11, characterized in that the connecting means (11) comprises a bayonet joint (27). 連結手段（１１）が弾性変形可能なカム（３１）を含み、プロテーゼ（１）と相手部材（６）との組立後にこのカムが相手部材に係止可能であることを特徴とする、請求項２〜１１のいずれか１項記載のプロテーゼ（１）。The connecting means (11) comprises a resiliently deformable cam (31), which can be locked to the counterpart after assembly of the prosthesis (1) and the counterpart (6). 12. The prosthesis (1) according to any one of 2 to 11. 少なくとも連結手段（１１）が中心軸線（４）と同軸で穴（２０）を備えており、プロテーゼ（１）がこの穴（２０）に導入可能なピンを含むことを特徴とする、請求項１３記載のプロテーゼ（１）。14. The device according to claim 13, wherein at least the coupling means (11) comprises a hole (20) coaxial with the central axis (4) and the prosthesis (1) comprises a pin which can be introduced into this hole (20). The described prosthesis (1). 連結手段（１１）が円錐体結合部を含むことを特徴とする、請求項２〜１１のいずれか１項記載のプロテーゼ（１）。Prosthesis (1) according to any of the claims 2 to 11, characterized in that the connecting means (11) comprises a cone connection. 連結手段（１１）がねじ結合部を含むことを特徴とする、請求項２〜１１のいずれか１項記載のプロテーゼ（１）。12. Prosthesis (1) according to any of the claims 2 to 11, characterized in that the coupling means (11) comprises a screw connection. プロテーゼ（１）が相手部材（６）内に受容可能な回転防止部を含むことを特徴とする、請求項１３〜１６のいずれか１項記載のプロテーゼ（１）。17. The prosthesis (1) according to any of the claims 13 to 16, characterized in that the prosthesis (1) comprises a resilient anti-rotation in the counterpart (6). 中間部分（２）の軸線方向凹部（５）が中間部分全体を貫通する連続した穴として構成されていることを特徴とする、請求項１記載のプロテーゼ（１）。2. Prosthesis (1) according to claim 1, characterized in that the axial recess (5) of the intermediate part (2) is configured as a continuous hole passing through the entire intermediate part. 中心軸線（４）と平行に見て延長部（３）の横断面が半円面であることを特徴とする、請求項１〜１８のいずれか１項記載のプロテーゼ（１）。19. Prosthesis (1) according to any of the preceding claims, characterized in that the cross section of the extension (3) is semi-circular when viewed parallel to the central axis (4). 請求項１〜１９のいずれか１項記載のプロテーゼ（１）用の相手部材において、
Ａ）相手部材（６）が内端（１４）と外端（１５）と；
Ｂ）この外端（１５）から出発して中心軸線（４）に対して半径方向および直径方向に延びる２つの延長部（３）とを含み、延長部が隣接する２つの椎骨の棘突起間空間に導入可能であり、さらに相手部材が
ｃ）内端（１４）に向けて栓（１６）を含み、この栓がプロテーゼ（１）の凹部（５）に導入可能であることを特徴とする相手部材。20. A mating member for a prosthesis (1) according to any one of claims 1 to 19,
A) The mating member (6) has an inner end (14) and an outer end (15);
B) two extensions (3) starting from this outer end (15) and extending radially and diametrically with respect to the central axis (4), the extensions being between the spinous processes of two adjacent vertebrae. Characterized in that it can be introduced into a space and that the mating member further comprises c) a plug (16) towards the inner end (14), which plug can be introduced into the recess (5) of the prosthesis (1). Mating member. 栓（１６）が連結手段（１１）を含み、この連結手段でプロテーゼ（１）が相手部材に固定可能であることを特徴とする、請求項２０記載の相手部材（６）。21. A mating member (6) according to claim 20, characterized in that the plug (16) comprises a connecting means (11) by means of which the prosthesis (1) can be fixed to the mating member. 連結手段（１１）が差込継手を含むことを特徴とする、請求項２１記載の相手部材（６）。The mating member (6) according to claim 21, wherein the connecting means (11) comprises a bayonet joint. 連結手段（１１）が弾性変形可能なカムを含み、相手部材（６）とプロテーゼ（１）との組立後にこれらのカムが相手部材に係止可能であることを特徴とする、請求項２１記載の相手部材（６）。22. The connecting means (11) comprises elastically deformable cams, which can be locked to the mating member after assembly of the mating member (6) and the prosthesis (1). (6). 連結手段（１１）が円錐体結合部を含むことを特徴とする、請求項２１記載の相手部材（６）。22. The mating member (6) according to claim 21, wherein the connecting means (11) comprises a cone connection. 連結手段（１１）がねじ結合部を含むことを特徴とする、請求項２１記載の相手部材（６）。22. The mating member (6) according to claim 21, wherein the coupling means (11) comprises a screw connection. プロテーゼ（１）が相手部材（６）内に受容可能な回転防止部を含むことを特徴とする、請求項２２〜２４のいずれか１項記載の相手部材（６）。25. A mating member (6) according to any of claims 22 to 24, characterized in that the prosthesis (1) comprises an anti-rotation part which can be received in the mating member (6). 中心軸線（４）と平行に見て延長部（３）の横断面が半円面であることを特徴とする、請求項２０〜２６のいずれか１項記載の相手部材（６）。27. The mating member (6) according to any of claims 20 to 26, characterized in that the cross section of the extension (3) is semi-circular when viewed parallel to the central axis (4). 相手部材（６）を有する棘突起間プロテーゼにおいて、組立状態のときプロテーゼが中心軸線（４）に直角な対称平面を有することを特徴とする棘突起間プロテーゼ（１）。An interspinous prosthesis (1) comprising a mating member (6), wherein the prosthesis has a plane of symmetry perpendicular to the central axis (4) when assembled. 請求項２０〜２６のいずれか１項記載の相手部材（６）を有する請求項１〜１９のいずれか１項記載の棘突起間プロテーゼ（１）。20. Interspinous process prosthesis (1) according to any one of claims 1 to 19, comprising a mating member (6) according to any one of claims 20 to 26. 棘突起間プロテーゼ（１）の延長部（３）が相手部材（６）の延長部に対して少なくとも２ｍｍ、好ましくは少なくとも３ｍｍの距離を有することを特徴とする、請求項２８または２９記載の相手部材（６）を有する棘突起間プロテーゼ（１）。30. A counterpart according to claim 28 or 29, characterized in that the extension (3) of the interspinous process prosthesis (1) has a distance of at least 2 mm, preferably at least 3 mm, relative to the extension of the counterpart member (6). An interspinous prosthesis (1) having a member (6). 棘突起間プロテーゼ（１）の延長部（３）が相手部材（６）の延長部に対して最大１５ｍｍ、好ましくは最大１２ｍｍの距離を有することを特徴とする、請求項２８〜３０のいずれか１項記載の相手部材（６）を有する棘突起間プロテーゼ（１）。31. The extension according to claim 28, characterized in that the extension (3) of the interspinous prosthesis (1) has a distance of at most 15 mm, preferably at most 12 mm, with respect to the extension of the mating member (6). An interspinous prosthesis (1) having a mating member (6) according to claim 1. 棘突起間プロテーゼ（１）が第１回転防止部を含み、相手部材（６）が第１回転防止部に相補的な第２回転防止部を含み、棘突起間プロテーゼ（１）の延長部（３）と相手部材（６）の延長部（３）が互いに一直線に並ぶ位置に移動可能であることを特徴とする、請求項２８〜３１のいずれか１項記載の相手部材（６）を有する棘突起間プロテーゼ（１）。The interspinous prosthesis (1) includes a first anti-rotation portion, the mating member (6) includes a second anti-rotation portion complementary to the first anti-rotation portion, and an extension ( 32. A mating member (6) according to any one of claims 28 to 31, characterized in that the (3) and the extension (3) of the mating member (6) are movable to a position in line with each other. Interspinous prosthesis (1).
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US7442208B2 (en) 2008-10-28
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US20040199255A1 (en) 2004-10-07
CA2495119A1 (en) 2003-02-27

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